It is conventional to store drugs, vaccines, medicaments and solutions in a sealed vial or other container for later use. Drugs, vaccines, medicaments and solutions may be stored in a dry or powdered form to increase the shelf life and reduce inventory space. Such dry or powdered materials may be stored in a conventional sealed vial having a pierceable closure, such as an elastomeric stopper, and reconstituted in liquid form for later use, such as administration to a patient, by adding a diluent or solvent for example. Alternatively, such drugs, vaccines, medicaments and solutions may be stored in a vial in a liquid or even a gaseous form. A conventional vial for storing such materials in liquid, dry or gaseous form includes an open end, a radial rim portion surrounding the open end and a reduced diameter neck portion adjacent the rim portion. The vial is conventionally sealed with an elastomeric stopper or other pierceable closure which generally includes a tubular portion inserted in the open end in the neck of the vial and a planar rim portion which overlies the vial rim. The stopper is conventionally secured to the vial with a thin malleable metal cap, such as aluminum. Because aluminum is malleable, the collar accommodates the buildup of tolerances of the dimensions on the stopper and vial rim.
Recently, various vial transfer sets have been proposed for transferring fluid between a vial and a conventional syringe, wherein the transfer set is mounted on the vial for later use. The transfer set may include a piercing member, such as a needle cannula, generally telescopically mounted in a tubular fluid transfer member mounted on the open end of the vial. The transfer set may be enclosed by a cup-shaped closure or housing having a radial flange secured to the vial by a malleable metal or plastic collar.
Transfer sets have been utilized, for example, to transfer fluid from a vial to a syringe, such as a reconstituted dry or powdered drug, vaccine or medicament by adding a diluent or solvent in the syringe. The reconstituted drug may then be withdrawn from the vial by the syringe. The inner surface of the transfer set may be part of the fluid path and the aluminum collar or ring may bring aluminum particles into the sterile room where the drug, vaccine or medicament is added to the vial or into the drug path contaminating the drug, vaccine or medicament. There have been attempts to reduce this problem by applying a protective coating to the aluminum cap or collar. Finally, the prior art also includes snap-on cup-shaped plastic caps or collars having radially inwardly projecting end portion which is snapped over the rim of the vial. Snap-on collars, however, do not assure adequate sealing of the vial or fully accommodate the tolerances of standard vials and stoppers, as required.
The prior art also discloses plastic transfer sets for vials. However, such plastic transfer sets are relatively expensive having several interfitting parts and are difficult to manufacture and use. The need therefore remains for a transfer set for vials or other containers which may be utilized with conventional containers used by the medical industry, which assures sealing of the container and which achieves a good level of cleanliness, without particles or dust which may contaminate the drugs, vaccines or medicaments, the transfer set or the clean room, and which does not expose the health care worker to sharp metal edges. The need also remains for a transfer set which may be easily secured to a vial or other container and which is relatively simple in construction and easy to use.